PET Imaging of MMP Activation in AAA: Clinical Component
ConditionAbdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
A first-in-human evaluation of \[64Cu\]-RYM2 with PET/CT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).
Eligibility criteria
Qualifiers
No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions.
Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol.
Capable of lying still and supine within the PET/CT scanner for ~1 hour and follow instructions for breathing protocol during the CT portion.
No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year.
Disqualifiers
Inability to receive and sign informed consent;
Pregnant (confirmed by urine pregnancy test) and/or breastfeeding
Patient with chronic renal disease whose glomerular filtration rate (GFR) is less than 30 mL/min/1.73 m2
Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study.
Trial design
Treatments tested in this trial
- Cu-64-RYM2
- PET imaging using Cu-64
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov